INDICATIONS AND USAGE In patients without structural heart disease, Flecainide Acetate Tablets USP are indicated for the prevention of: β’ paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms β’ paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide Acetate Tablets USP are also indicated for the prevention of: β’ documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life-threatening. Use of Flecainide Acetate Tablets USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of Flecainide Acetate Tablets USP is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of Flecainide Acetate Tablets USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide Acetate Tablets USP should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS ). Use of Flecainide Acetate Tablets USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed WARNINGS ). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of Flecainide Acetate Tablets USP favorably affects survival or the incidence of sudden death.
ani pharmaceuticals, inc.
HOW SUPPLIED Flecainide Acetate Tablets USP are available as: 50 mg: white to off-white, round, flat-faced, beveled-edge, unscored tablet debossed with βANIβ on one side and β380β on the other side. They are available in bottles of 100 tablets. (NDC 62559-380-01). 100 mg: white to off-white, oval, flat-faced, beveled-edge, scored tablet. One side of the tablet is unscored and debossed with βANIβ. The other side of the tablet is scored and debossed β381β on one side of the score and β100β on the other. They are available in bottles of 100 tablets. (NDC 62559-381-01). 150 mg: white to off-white, oval, flat-faced, beveled-edge, scored tablet. One side of the tablet is unscored and debossed with βANIβ. The other side of the tablet is scored and debossed β382β on one side of the score and β150β on the other. They are available in bottles of 100 tablets. (NDC 62559-382-01). Store at 20Β° to 25Β°C (68Β° to 77Β°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9786 Rev 12/15 ani
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